An Open Label Trial of TMC114/RTV in HIV-1 Infected, Treatment-experienced Subjects.
TMC114
Enfermedades Transmisibles+10
+ Enfermedades Urogenitales
+ Infecciones Transmitidas por la Sangre
Estudio de Tratamiento
Resumen
Fecha de inicio: 1 de noviembre de 2003
Fecha en la que se inscribió al primer participante.The study will continue for 144 weeks after study medication has begun. For patients failing treatment, they must have participated in the TMC114-C213 or TMC114-C202 for at least 12 weeks and meet specific virologic failure criteria. It is estimated that approximately 150 patients may meet these criteria. Major inclusion and exclusion criteria are listed below. For new patients, they must have been on prior antiretroviral therapy, including more than one nucleoside reverse transcriptase inhibitor (NRTI), one non-nucleoside reverse transcriptase inhibitor (NNRTI) and a protease inhibitor (PI). At least one primary PI mutation must be present at screening. Many of the same centers that are participating in the TMC114-C213 and TMC-114 -C202 studies are also participating in the TMC114-C215 study. All sites have the chance to recruit rollover patients into the TMC114-C215 study and some sites listed had approval to recruit new patients into the study. The recruitment of new patients for the TMC114-C215 trial has been fully enrolled. The TMC114-C202 and TMC114-C213 have completed so no more patients are enrolled in this study. Two 300mg/100mg Darunavir/Ritonavir tablets twice daily for 144 weeks.
Protocolo
Esta sección proporciona detalles del plan del estudio, incluyendo cómo está diseñado y qué se está evaluando.Se reclutarán 555 pacientes
Número total de participantes que el ensayo clínico espera reclutar.Estudio de Tratamiento
Elegibilidad
Los investigadores buscan pacientes que cumplan ciertos criterios, conocidos como criterios de elegibilidad: estado general de salud o tratamientos previos.Cualquier sexo
Sexo biológico de los participantes elegibles para inscribirse.A partir de 18 años
Rango de edades de los participantes que pueden unirse al estudio.Voluntarios sanos no permitidos
Indica si personas sanas, sin la condición que se estudia, pueden participar.Condiciones
Patología
Criterios
Inclusion Criteria: * Previous participation in the TMC114-C202 or TMC114-C213 trials * Significant virologic failure during participation in the above trials * Study participation in the treatment phase of the original trial for a total of at least 12 weeks before TMC114-C215 screening * Patient agrees to take TMC114/RTV with at least 2 other antiretrovirals (NRTIs), with or without T-20, from baseline onwards * Patient has given informed consent Exclusion Criteria: * Use of disallowed concomitant therapy * Patient with clinical or laboratory evidence of active liver disease, liver impairment/ dysfunction or cirrhosis irrespective of liver enzyme levels * Any active or unstable medical condition that, in the investigator's opinion, would compromise the subject's safety * Patient with laboratory abnormalities at screening as defined by ACTG grading scheme as listed in the protocol * Patient withdrawing consent from TMC114-C202 or TMC114-C213
Plan de Estudio
Conoce todos los tratamientos administrados en este estudio, su descripción detallada y en qué consisten.Un solo grupo de intervención está designado en este estudio
0% de probabilidad de ser asignado al grupo placebo
Grupos de Tratamiento
Grupo I
ExperimentalObjetivos del Estudio
Objetivos Primarios
Objetivos Secundarios